PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8 recalled over sterility concerns

Recall date

December 22, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pharmacy Innovations recalls PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 100MCG/8.7MG/0.1MG…

Recall number

D-0227-2023

FDA classification

Class II

Brand / firm

Pharmacy Innovations

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 100MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 15MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 30MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.